An exciting opportunity is available for a Senior Engineering Specialist (Validation) to join a team in Carlow, working in a dynamic and regulated cGMP environment.
Key Responsibilities
What You Will Do:
* Design, author, review, approve, and execute qualification/validation documentation and cycle development studies.
* Execute and manage change controls.
* Resolve technical issues during study execution.
* Collaborate with production, maintenance, and quality teams during validation activities.
* Provide technical input on quality notifications, including investigations.
* Perform root cause analysis of system failures using standard tools and methods.
* Support continuous improvement via Lean Six Sigma methodologies.
* Represent validation on cross-functional projects and in global technical forums.
* Ensure compliance with global policies, procedures, regulatory standards, and cGMP in all activities.
* Maintain documentation, conduct risk assessments, and participate in audits and inspections.
* Support regulatory audits and submissions.
* Promote a culture of safety and compliance.
* Perform additional duties as assigned.
Experience, Knowledge & Skills
What You Will Need:
* Demonstrated experience in cleaning validation, including:
* Cleaning development (CD) and performance qualification (PQ) of mobile vessels (CIP) and parts washers (COP)
* Recipe development and optimisation
* Cleaning verification, cleanability and recovery studies using TOC, ICP, and swab methods
* Determination of acceptable residual limits
* Development of worst-case soil matrices and validation strategy
* Experience in a GMP manufacturing setting, ideally as an individual contributor with:
* Exception/deviation management and change control
* Technical project leadership experience
* Technical background in:
* Applied Pharmaceutical, Biological, Chemical Sciences, or a related Technical/Engineering qualification
* Familiarity with:
* Process monitoring systems
* Automation systems (e.g., DeltaV)
* Operational intelligence/data systems (e.g., PI System)
* Excellent report writing, policy drafting, and documentation skills
* Strong analytical skills with ability to interpret complex data
* Solid understanding of Irish, European, and international regulatory/code requirements
* Proficiency in Microsoft Office and relevant computer applications
* Strong communication, presentation, and interpersonal skills
Desirable Experience
Knowledge or experience in the following areas will be considered an advantage:
* Filter Validation
* Container Closure Integrity (CCI) Qualification
* Shipping Qualification
* Equipment Periodic Validation
* Equipment Validation Lifecycle
* Project Management
* Autoclave/SIP Sterilisation Validation
* Dry Heat Sterilisation
* Isolator VHP/HVAC Qualification
* Controlled Temperature Units/Equipment Qualification
* Vial and Syringe Processing Technologies
Qualifications & Education
* Relevant technical qualification(s) in Applied Pharmaceutical, Biological, or Chemical Sciences, or in an applied Technical/Engineering field.
Apply today!
#J-18808-Ljbffr